title: The HVTN503/Phambili HIV vaccine trial: a comparison of younger and older participants.
abstract: By comparing younger to older participants enrolled in a HIV vaccine efficacy trial, we aimed to gain insights into the inclusion of adolescents in future trials. This was a sub-analysis of a multisite HIV vaccine randomized clinical trial in South Africa, conducted January-September 2007. Motivations for trial enrolment, social harms, adverse events and loss to follow-up were compared between younger (18-20 years old) and older participants (21-35 years old). Both younger (n = 238) and older participants (n = 563) were equally likely to report enrolling for altruistic reasons. Younger females were less likely than older participants to join for trial reimbursement (p = 0.005), while younger males were more likely to enrol because the vaccine may provide protection from HIV-acquisition (p < 0.001). There were no significant differences in the number of social harms reported. Compared to males over 20 years old, 18-20-year-old females were less likely to experience adverse events (OR = 0.1, CI 0.01-0.80) and no more likely to be lost to follow-up (OR = 0.7, CI 0.39-1.25), while 18-20-year-old males were no more likely to experience adverse events (OR = 1.3, CI 0.58-2.83) or loss to follow-up (OR = 0.8, CI 0.51-1.41). Our data support the inclusion of younger participants who are at risk for HIV in future HIV vaccine efficacy trials.
authors.affiliation: Bridge HIV, Department of Public Health, San Francisco, CA, USA.
authors.forename: Jonathan E
authors.initials: JE
authors.lastname: Volk
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Hessol
authors.forename: Glenda E
authors.initials: GE
authors.lastname: Gray
authors.forename: James G
authors.initials: JG
authors.lastname: Kublin
authors.forename: Gavin J
authors.initials: GJ
authors.lastname: Churchyard
authors.forename: Koleka
authors.initials: K
authors.lastname: Mlisana
authors.forename: Maphoshane
authors.initials: M
authors.lastname: Nchabeleng
authors.forename: Susan P
authors.initials: SP
authors.lastname: Buchbinder
authors.forename: Linda-Gail
authors.initials: LG
authors.lastname: Bekker
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000276:immunology; D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D002986:Clinical Trials as Topic; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D009042:Motivation; D010358:Patient Participation / Q000706:statistics & numerical data*; D018579:Patient Selection; D013019:South Africa; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines
keywords: AIDS; HIV; South Africa; clinical trials; prevention; vaccination; vaccine trials; youth